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Associate Director, Regulatory Strategy
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Proclinical, in support of our client, are seeking an individual to fill the role of The Associate Director of Regulatory Strategy, based in Massachusetts. The successful candidate will facilitate drug development through identification and resolution of scientific and regulatory issues. Additionally, they will be responsible for formulating the regulatory strategies for assigned development projects.
Responsibilities
- Formulate regulatory strategies that provide a streamlined development programs while accurately interpreting and reflecting regulatory and corporate guidelines.
- Plan and manage integration of multidisciplinary regulatory programs into the project team development plans.
- Lead the planning and conduct of meetings with regulatory agencies as appropriate. May represent at regulatory agency meetings.
- Address current and proposed regulatory, scientific and pertinent legal issues.
- Ensure that all documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review.
Skills And Qualifications
- BA, BS or higher in health-related field, with 7+ years of regulatory experience.
- Demonstrate personal leadership and collaboration skills
- Knowledge of drug development process is essential.
- Knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience.
- Prior experience working with FDA or EMA.
- Experience of successful NDA, BLA or MAA is filing essential.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kyle Weber at (+1) 646-367-2618 or upload your resume on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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